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74 Illumina Jobs
Staff IT Security, Risk & Compliance Analyst
Illumina
posted 19hr ago
Job Role Insights
Key skills for the job
Job Description
- Advises project teams and internal GIS customers on validation scope, risk, and validation approach.
- Operate independently to manage end to end compliance activities within projects.
- Develops and maintains software and hardware testing protocols (knowledge of different types of testing such as integration, unit, regression testing).
- Responsible for Validation Documentation.
- Participates in project and system requirements gathering/authoring, coordinates activities with business users and analysts.
- Coordinates the Change Management process within the GIS organization.
- Reviews system changes to provide compliance assessments and closure summaries that are audit ready.
- Investigates root-cause of defects, failures, and authors and/or investigates Non-conformances and CAPAs.
Requirements:
- 7+ years of experience working in Life sciences industry focusing on Computer Systems Validation.
- Strong oral and written skills to persuade, direct and advise stakeholders on regulatory compliance processes.
- Strong organizational skills to maintain and manage multiple validation projects.
- Experience with enterprise applications such as SAP, LMS, Salesforce and EtQ, etc.
- Experience with Test Management Tools such as HP Quality Center, ValGenesis and TFS.
- Ability to articulate risk-based validation strategy and provide validation approach to meet the business needs.
- Excellent customer service and communication skills.
- Experience with regulations and frameworks - e.g., 21 CFR Part 820/11, ISO 13485, and GAMP.
- Experience with software development lifecycle activities, methodologies, testing and validation.
- Experience managing workload using IT Service Management ticketing tools, ServiceNow preferred.
- Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS.
People Leadership:
- Ensure Policies and Procedures are followed by direct reports
- Work with onshore leads for new and/or altering work assignments
Experience/Education:
- Typically requires a minimum of 7 years of related experience with a bachelor s degree; or 5 years and a Master s degree
Employment Type: Full Time, Permanent
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